CONSORT Diagram

Recruitment Coupons

Screen 1 Pre-Eligible

scr1_eligibility Count Percent
Not eligible 625 73.6
Pre-eligible 224 26.4

Cumulative Number First Stage Screening by Date

Medication Adherence and Viral Load Among Ineligible Participants

Medication Adherence (0-100)

n Mean sd Median IQR Min Max
174 73 28 82 50 0 100

Completion of Viral Load Testing Within Past Six Months

scr1_meds_past6wks_q2 Count Percent
No 14 8.0
Yes 159 91.4
Don’t Know 1 0.6

Self-Reported Undetectable Viral Load Among Ineligible with Viral Load Testing Within Past Six Months

scr1_meds_past6wks_q3 Count Percent
No - not undetectable 35 22.0
Yes - undetectable 115 72.3
Don’t Know result 9 5.7

Screen 2A Pre-Eligible

scr2a_prelim_eligibility Count Percent
Pre-eligible 155 100

Cumulative Number Stage 2A Screening by Date

Screen 2B Final Eligibility

scr2b_final_eligibility Count Percent
No: Not Eligible 89 59.7
Yes: Eligible 60 40.3

Cumulative Number Final Stage Screening by Date

Screening Weekly Totals

First Stage

Week Pre-eligible Ineligible Total Cumulative Pre-Eligible Cumulative Ineligible Cumulative Total Eligibility Rate
March 20, 2017 1 8 9 1 8 9 11.1
March 27, 2017 4 15 19 5 23 28 17.9
April 03, 2017 3 5 8 8 28 36 22.2
April 10, 2017 3 5 8 11 33 44 25.0
April 17, 2017 8 29 37 19 62 81 23.5
April 24, 2017 7 25 32 26 87 113 23.0
May 01, 2017 5 31 36 31 118 149 20.8
May 08, 2017 4 15 19 35 133 168 20.8
May 15, 2017 13 27 40 48 160 208 23.1
May 22, 2017 7 11 18 55 171 226 24.3
May 29, 2017 2 15 17 57 186 243 23.5
June 05, 2017 6 11 17 63 197 260 24.2
June 12, 2017 3 12 15 66 209 275 24.0
June 19, 2017 12 28 40 78 237 315 24.8
June 26, 2017 13 49 62 91 286 377 24.1
July 03, 2017 14 32 46 105 318 423 24.8
July 10, 2017 8 49 57 113 367 480 23.5
July 17, 2017 5 31 36 118 398 516 22.9
July 24, 2017 17 35 52 135 433 568 23.8
July 31, 2017 5 9 14 140 442 582 24.1
August 07, 2017 5 19 24 145 461 606 23.9
August 14, 2017 9 27 36 154 488 642 24.0
August 21, 2017 16 37 53 170 525 695 24.5
August 28, 2017 14 35 49 184 560 744 24.7
September 04, 2017 14 18 32 198 578 776 25.5
September 11, 2017 19 36 55 217 614 831 26.1
September 18, 2017 7 11 18 224 625 849 26.4

Stage 2A

Week Pre-eligible Ineligible Total Cumulative Pre-Eligible Cumulative Ineligible Cumulative Total Eligibility Rate
March 27, 2017 2 0 2 2 0 2 100
April 03, 2017 4 0 4 6 0 6 100
April 10, 2017 3 0 3 9 0 9 100
April 17, 2017 7 0 7 16 0 16 100
April 24, 2017 3 0 3 19 0 19 100
May 01, 2017 4 0 4 23 0 23 100
May 08, 2017 7 0 7 30 0 30 100
May 15, 2017 9 0 9 39 0 39 100
May 22, 2017 6 0 6 45 0 45 100
June 05, 2017 7 0 7 52 0 52 100
June 12, 2017 1 0 1 53 0 53 100
June 19, 2017 12 0 12 65 0 65 100
June 26, 2017 6 0 6 71 0 71 100
July 03, 2017 6 0 6 77 0 77 100
July 10, 2017 8 0 8 85 0 85 100
July 17, 2017 3 0 3 88 0 88 100
July 24, 2017 14 0 14 102 0 102 100
July 31, 2017 5 0 5 107 0 107 100
August 07, 2017 6 0 6 113 0 113 100
August 14, 2017 8 0 8 121 0 121 100
August 21, 2017 9 0 9 130 0 130 100
August 28, 2017 13 0 13 143 0 143 100
September 04, 2017 4 0 4 147 0 147 100
September 11, 2017 7 0 7 154 0 154 100
September 18, 2017 1 0 1 155 0 155 100

Final Stage

Week Eligible Ineligible Total Cumulative Eligible Cumulative Ineligible Cumulative Total Eligibility Rate
March 27, 2017 1 0 1 1 0 1 100.0
April 03, 2017 1 2 3 2 2 4 50.0
April 10, 2017 1 4 5 3 6 9 33.3
April 17, 2017 1 3 4 4 9 13 30.8
April 24, 2017 4 1 5 8 10 18 44.4
May 01, 2017 1 2 3 9 12 21 42.9
May 08, 2017 3 3 6 12 15 27 44.4
May 15, 2017 5 7 12 17 22 39 43.6
May 22, 2017 2 3 5 19 25 44 43.2
May 29, 2017 1 0 1 20 25 45 44.4
June 05, 2017 3 3 6 23 28 51 45.1
June 12, 2017 1 1 2 24 29 53 45.3
June 19, 2017 3 7 10 27 36 63 42.9
June 26, 2017 2 4 6 29 40 69 42.0
July 03, 2017 5 2 7 34 42 76 44.7
July 10, 2017 3 4 7 37 46 83 44.6
July 17, 2017 1 3 4 38 49 87 43.7
July 24, 2017 5 8 13 43 57 100 43.0
July 31, 2017 1 5 6 44 62 106 41.5
August 07, 2017 4 2 6 48 64 112 42.9
August 14, 2017 3 5 8 51 69 120 42.5
August 21, 2017 1 8 9 52 77 129 40.3
August 28, 2017 5 8 13 57 85 142 40.1
September 04, 2017 2 2 4 59 87 146 40.4
September 11, 2017 1 2 3 60 89 149 40.3

Enrolled

Week Week Number Total Enrolled Cumulative Total Enrolled Cumulative Target
April 03, 2017 1 1 1 5
April 10, 2017 2 1 2 10
April 17, 2017 3 1 3 15
April 24, 2017 4 3 6 20
May 01, 2017 5 2 8 25
May 08, 2017 6 2 10 30
May 15, 2017 7 3 13 35
May 22, 2017 8 3 16 40
May 29, 2017 9 3 19 45
June 05, 2017 10 1 20 50
June 19, 2017 11 5 25 55
June 26, 2017 12 2 27 60
July 03, 2017 13 1 28 65
July 10, 2017 14 4 32 70
July 17, 2017 15 2 34 75
July 24, 2017 16 2 36 80
July 31, 2017 17 4 40 85
August 07, 2017 18 1 41 90
August 14, 2017 19 5 46 95
August 28, 2017 20 1 47 100
September 04, 2017 21 2 49 105
September 11, 2017 22 5 54 110
September 18, 2017 23 1 55 115

Screening Activities Completed

Screening Activity Count
First Stage Screening Complete 849
First Stage Screening Ineligible 625
First Stage Screening Pre-Eligible 224
Second Stage Screening Complete 155
Second Stage Screening Ineligible 0
Second Stage Screening Pre-Eligible 155
Hair Sample Collected 42
Hair Results Available 0
Blood Sample Collected 152
Blood Results Available 149
Final Stage Screening Complete 149
Final Stage Screening Ineligible 89
Final Stage Screening Eligible 60

Randomization

Condition Count Percent
BEAR 4 7.3
CAT 8 14.5
DOG 2 3.6
EAGLE 2 3.6
FISH 6 10.9
GOAT 2 3.6
HORSE 4 7.3
LION 1 1.8
MOTH 2 3.6
OWL 8 14.5
PANDA 4 7.3
RABBIT 3 5.5
SNAKE 4 7.3
TIGER 1 1.8
WHALE 4 7.3

Cumulative Number Assigned to Each Study Condition by Date

Activities Completed

Activity Complete Unverified Incomplete
baseline_interview_complete 55 0 2
blood_draw_form_complete 58 0 5
core_component_form_complete 47 1 6
follow_up2_interview_complete 6 0 0
hair_sample_form_complete 0 0 6
health_coach_notes_form_complete 2 0 5
health_coach_session_1_complete 5 0 2
locator_form_complete 83 69 3
long_navigation_form_complete 0 15 0
mi_session_1_complete 21 0 0
mi_session_2_complete 17 0 2
mi_session_3_complete 13 0 1
mi_session_4_complete 9 0 0
navigation_action_plans_form_complete 0 17 14
navigation_assessment_form_complete 29 1 1
navigation_final_session_complete 4 0 0
navigation_session_1_complete 28 1 2
pap_session_1_complete 5 0 1
participant_basic_info_form_complete 47 0 7
provider_question_list_complete 0 0 31
randomization_check_form_complete 51 0 3
randomization_form_complete 55 0 0
short_navigation_form_complete 0 15 0
support_group_form_complete 7 0 0

Demographics

Screen 1 Participants (n=848)

Crosstabulation of Gender and Race/Ethnicity

Gender Race-Ethnicity Group Count Percent
Male American Indian or Alaskan 2 0.2
Female American Indian or Alaskan 1 0.1
Refuse to Answer American Indian or Alaskan 0 0.0
Male Asian or Pacific Islander 2 0.2
Female Asian or Pacific Islander 0 0.0
Refuse to Answer Asian or Pacific Islander 0 0.0
Male Black, Not of Hispanic American Origin 374 44.1
Female Black, Not of Hispanic American Origin 212 25.0
Refuse to Answer Black, Not of Hispanic American Origin 1 0.1
Male Hispanic American 143 16.9
Female Hispanic American 56 6.6
Refuse to Answer Hispanic American 0 0.0
Male White, Not of Hispanic American Origin 12 1.4
Female White, Not of Hispanic American Origin 8 0.9
Refuse to Answer White, Not of Hispanic American Origin 0 0.0
Male Other or Unknown 22 2.6
Female Other or Unknown 15 1.8
Refuse to Answer Other or Unknown 0 0.0

Gender Totals

Gender Count Percent
Female 292 34.4
Male 555 65.4
Refuse to Answer 1 0.1

Race/Ethnicity Group Totals

Race-Ethnicity Group Count Percent
American Indian or Alaskan 3 0.4
Asian or Pacific Islander 2 0.2
Black, Not of Hispanic American Origin 587 69.2
Hispanic American 199 23.5
White, Not of Hispanic American Origin 20 2.4
Other or Unknown 37 4.4

Age

n Mean SD Min First Quartile Median Third Quartile Max
848 49.9 10.8 17 44 52 57 76

Enrolled Participants (n=55)

Crosstabulation of Gender and Race/Ethnicity

Gender Race-Ethnicity Group Count Percent
Male American Indian or Alaskan 0 0.0
Female American Indian or Alaskan 0 0.0
Male Asian or Pacific Islander 0 0.0
Female Asian or Pacific Islander 0 0.0
Male Black, Not of Hispanic American Origin 21 38.2
Female Black, Not of Hispanic American Origin 16 29.1
Male Hispanic American 12 21.8
Female Hispanic American 3 5.5
Male White, Not of Hispanic American Origin 0 0.0
Female White, Not of Hispanic American Origin 0 0.0
Male Other or Unknown 2 3.6
Female Other or Unknown 1 1.8

Gender Totals

Gender Count Percent
Female 20 36.4
Male 35 63.6
Refuse to Answer 0 0.0

Race/Ethnicity Group Totals

Race-Ethnicity Group Count Percent
American Indian or Alaskan 0 0.0
Asian or Pacific Islander 0 0.0
Black, Not of Hispanic American Origin 37 67.3
Hispanic American 15 27.3
White, Not of Hispanic American Origin 0 0.0
Other or Unknown 3 5.5

Age

n Mean SD Min First Quartile Median Third Quartile Max
55 46.2 10.6 20 37 50 54 62

Eligibility Rate Over Time

Overall

By Recruitment Approach